MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGU343415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Vascular Dissection (3160)
Date of Event	05/21/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to cardiac arrhythmia, hypotension and death.
Event or Problem Description
The following information was reported to gore through the (b)(6) study for the gore® tag® thoracic branch endoprosthesis (tbe device): on (b)(6) 2018, the patient underwent endovascular treatment of a thoracic dissection in (zone 0/1), and was implanted with a gore® tag® thoracic branch endoprosthesis.The patient tolerated the procedure.On (b)(6) 2020 rapid expansion of the aortic arch, proximal and distal descending aorta and visceral segment were reported.Retrograde flow into the false lumen at the level of the supraceliac aorta was also reported.Thoracoabdominal aneurysm repair with left heart bypass was performed but the patient developed profound hypotension and ventricular fibrillation.Despite defibrillation and cardiac compressions, the patient expired intraoperatively.
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® tag® thoracic branch endoprosthesis (tbe device): on (b)(6) 2018, the patient underwent endovascular treatment of a thoracic dissection in (zone 0/1), and was implanted with a gore® tag® thoracic branch endoprosthesis (ctag).The patient tolerated the procedure.On (b)(6) 2020 rapid expansion of the aortic arch, proximal and distal descending aorta and visceral segment were reported.This rapid expansion was not within the treatment zone.It was adjacent to the ctag device.Retrograde flow into the false lumen at the level of the supraceliac aorta was also reported.Open thoracoabdominal repair with left heart bypass was performed but the patient developed profound hypotension and ventricular fibrillation.Despite defibrillation and cardiac compressions, the patient expired intraoperatively due to exsanguination.
Additional Manufacturer Narrative
B.5.Updated.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10146005
• Report Number: 2017233-2020-00432
• Device Sequence Number: 3300379
• Product Code: MIH
• UDI-Device Identifier: 00733132618156
• UDI-Public: 00733132618156
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2021
• Device Model Number: TGU343415
• Device Catalogue Number: TGU343415
• Device Lot Number: 18316649
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 44 YR
• Patient Weight: 76